The development of apparatus and techniques for maintaining the sterility of catheters, such as thermodilution flow-directed balloon catheters used for measuring cardiac output and for obtaining other diagnostic data, has received critical attention as the use of such products has expanded. The packaging of the catheter in gas-sterilizable containers and in single-use kits having all of the items needed for insertion of the catheter and for use in carrying out the required procedure and by rigorously following sterile procedures have all contributed to a substantially reduced risk of contamination and infection. However, even when following the most rigorous procedures contamination may occur, particularly when the patient is being treated under emergency conditions. At best, a potentially contaminated catheter may have to be discarded prior to use when sterile procedures have not been followed.
A form of sterility sleeve used to maintain a portion of an indwelling catheter free from contamination for later use when it becomes necessary to re-position the catheter is disclosed in U.S. Pat. No. 4,327,723 to Paul L. Frankhouser. This sleeve is extended over a length of catheter immediately adjacent to the portion inserted into the vascular system of the patient, thereby physically isolating a reserve section of catheter from the atmosphere for use should it later become necessary to reposition the catheter.
U.S. Pat. No. 4,568,334 to Lawrence Lynn discloses a means for more comprehensive treatment of the contamination problem. In the Lynn patent, a combined storage, dispensing and preparation container is provided for an intravascular balloon catheter. The container includes a plurality of interconnected compartments in which different parts of the catheter are housed. Lynn's compartments include a test chamber for testing the integrity of the catheter balloon, an adjacent section in which a pleated sleeve is housed in what is termed a "trough compartment," a main compartment in which a substantial section of catheter may be stored and a connector compartment in which the proximal end of the catheter is located. The distal tip of the catheter is withdrawn from the test chamber once balloon integrity is tested, until the tip is located within the pleated sleeve by a pumping action of the sleeve. The pleated sleeve is then attached to a catheter introducer in place within the patient's blood vessel and the catheter is then advanced into the vessel by a reverse pumping action of the sleeve.
U.S. Pat. No. 4,622,033 to Taniguchi discloses a packaging construction for a urinary catheter comprising a lubricant reservoir and a tubular envelope or shield. A balloon-tipped urinary catheter is advanced into the lubricant reservoir prior to use. The lubricant reservoir has a frangible seal so that the reservoir can be removed once the catheter has been lubricated.
U.S. Pat. No. 4,637,404 to Gessman discloses a dispensing container for a cardiac pacing electrode in which a flexible sheath or sleeve comprising an accordion section 32 and another gathered or accordion section 34 is provided for advancing the electrode by grasping the wire through the sleeve.